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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03123835
Other study ID # 676956
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date March 2016
Est. completion date December 2031

Study information

Verified date October 2023
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluation of current and newly developed endoluminal therapies in the management of Upper and Lower GI conditions.


Description:

Over the last few years there have been numerous advances in the use of endoscopic equipment and related treatments in the identification and intervention of gastrointestinal diseases. Many of these treatments using flexible endoscopes have either complimented or replaced surgical approaches to these same benign and malignant disease processes with the potential of being the standard of care for many of these clinical conditions. The initial primary focus of this study will be the use of endoscopic myotomy for achalasia, endoscopic treatment of post bariatric weight gain, endoscopic gastro-gastric fistula treatments, and other endoluminal therapies for gastrointestinal and post-operative conditions. These treatments have been validated by prior surgery studies.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 500
Est. completion date December 2031
Est. primary completion date December 2030
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Adult male and female patients 18-80 years of age - Meet the criteria for surgery of benign and/or malignant gastrointestinal pathology(s) - Gastrointestinal Reflux Disease - Achalasia - Barrett's Esophagus - Post Bariatric Surgery conditions - Other gastrointestinal and postsurgical disorders. Exclusion Criteria: - Adults unable to consent - Individuals that do not meet inclusion criteria or qualify for endoluminal treatment paradigms and internees.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Endoscopic Intervention
After reviewing all therapeutic options the patient will be offered the best therapeutic option to treat their condition. Surgical interventions include open laparotomy, diagnostic/therapeutic laparoscopy or endoluminal therapies. After the patient is consented for the related surgical intervention the patient will be given the option to participate in the clinical study to measure outcomes after surgery.

Locations

Country Name City State
United States Univesity of California Davis Health System Sacramento California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Decrease in GERDDQ Assessment will be made via post surgery questionnaire (decreasing in scoring will be 0-5) 3-6 months
Secondary Decrease in Eckardt scoring Decrease in overall GERD symptoms using Eckardt Scoring methodology (5-0) 30 days
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